Change Control Analyst
Role details
Job location
Tech stack
Job description
- Lead structured data retrieval and collection efforts across internal systems such as PLM, ERP, and Quality Management Systems (QMS), as well as from external suppliers, to support PEC regulatory requirements.
- Compile, cleanse, and validate complex datasets to ensure accuracy, traceability, and readiness for regulatory submissions and internal reporting.
- Partner cross-functionally with Engineering, Supply Chain, Regulatory, Quality, and external suppliers to obtain material, component, and product-level compliance data.
- Create and manage Enterprise Change Notices (ECNs) within the Quality Management System to implement updates tied to PEC findings, ensuring documentation and data inputs are compliant and audit-ready.
- Translate regulatory requirements into clear data needs by identifying required attributes, documentation, and evidence to support compliance initiatives.
- Support supplier engagement and outreach by requesting, tracking, and following up on material declarations, certifications, and compliance documentation.
- Perform data analysis and gap assessments to identify missing, inconsistent, or incomplete information and drive resolution with relevant stakeholders.
- Maintain and update project tracking tools and dashboards to provide visibility into data collection progress, risks, and completion status across PEC programs.
- Contribute to continuous improvement by standardizing data collection methods, templates, and workflows to enhance efficiency and scalability of PEC efforts.
- Act as Change Owner as needed, coordinating implementation plans and ensuring execution aligns with regulatory timelines.
- Build strong cross-functional relationships to gather, validate, and align data across global teams, suppliers, and systems.
- Proactively identify gaps in data availability, quality, and processes and recommend enhancements to data collection and reporting mechanisms., This is a hybrid position based in Kalamazoo, Michigan, with a typical schedule of approximately 40 hours per week. Initial training will require more time onsite, including completion of required trainings and job shadowing during the first 60 days, after which more independent work will begin. A hybrid schedule is typically set at 2-4 days onsite weekly, based on performance. The role follows Eastern Time Zone working hours, with some flexibility to start around 8:00 or 9:00 a.m. You will work closely with a Product Environmental Compliance (PEC) core team of 5-6 people and engage with 8 additional sub-teams, collaborating via digital tools such as Teams and enterprise systems including PLM, ERP, and QMS. The environment is fast-paced, collaborative, and data-driven, with a strong emphasis on regulatory compliance, audit readiness, and continuous improvement.
Requirements
- 1-3 years of experience in change management or change control, preferably involving engineering change orders or engineering change management.
- Strong attention to detail with the ability to manage, interpret, and validate complex datasets from multiple sources.
- Demonstrated ability to gather, analyze, and verify data across PLM, ERP, QMS, and other enterprise systems.
- Excellent communication skills, with the ability to collaborate effectively across diverse, global teams and external suppliers.
- Strong organizational and project management capabilities, including managing multiple data collection and change control activities concurrently.
- Ability to work in a fast-paced environment while maintaining high-quality, compliant outputs aligned with PEC requirements.
Additional Skills & Qualifications
- Preference for a Bachelor's degree in Engineering or a related field, or higher-level education with an engineering mindset.
- Experience in change control or change management within a regulated industry.
- Experience in the medical device industry and familiarity with medical device quality systems.
- Familiarity with Product Environmental Compliance (PEC) regulations such as REACH, RoHS, and PFAS.
- Experience with PLM tools, such as Windchill or onePLM, or similar product lifecycle management systems.
- Experience working with supplier data collection, material declarations, certifications, and compliance documentation.
- Ability to quickly learn and apply PEC-related processes and tools through training and job shadowing.
- Comfort working with project tracking tools and dashboards to monitor progress and risks.
Benefits & conditions
This is a Contract position based out of Portage, MI.
Pay and Benefits
The pay range for this position is $33.00 - $38.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type